GSK is leading the Ebola vaccine race! Get ready for $100+ a share!
This is older news, but GSK is clearly leading the Ebola vaccine race and it's do it out in only two weeks from now. I believe GSK is going low key so they can begin accumulating shares.
In about two weeks from now, GSK will easily be trading in the $125 range.
GSK's only competitor in the great Ebola vaccine race is MERCK, but they had significant side effects leading to severe joint pain. That's one vaccine to stay away from. GSK is running away with this one!
older news...
Two Anti-Ebola Vaccines in Historic Race.
One of the most rapidly fast-tracked vaccines in history—an anti-Ebola “ChAd3” vaccine—just entered clinical trial in humans. It may wrap in November. It protected macaques for five weeks, leaping to 10 months when followed by a booster two months later. It was the first demonstration of durable immunity against Ebola.
There are problems. Five weeks isn’t long. Boosters are impractical, as re-finding patients in the field can be a nightmare. And durable immunity with that vaccine has been shown only against a mild lab form of Ebola—not Africa's harsher Ebola.
But a second fast-tracked anti-Ebola vaccine—called an “rVSV” vaccine—is hot on its heels, entering trial at month’s end. That vaccine may be more effective, proponents say. One shot may offer a year of protection.
There is a problem there, too. Published proof exists of its short-term--not yet its durable--immunity. A paper this year found an rVSV vaccine offered an impressive 14 months of immunity. But that was in monkeys with Marburg—a virus close to Ebola, not identical (perhaps less virulent, for example.) By contrast, the durable-immunity ChAd3 vaccine work was published Sunday, in Nature Medicine.
Still, Marburg is similar enough that its data has excited Ebola researchers, said rVSV vaccine co-developer Thomas Geisbert of the University of Texas Medical Branch in an interview with DDD. And data have been presented to conferences showing a similar rVSV vaccine—by Profectus Biosciences—protected non-human primates from Ebola for at least 28 days, he said. Finally, as the rVSV vaccine is replication-competent, Geisbert thinks it will provide more durable immunity than the ChAd3 vaccine “by a landslide.”
But the main reason these two vaccines are fast-tracking is Ebola itself. A World Health Organization (WHO) meeting of 200 top virologists last week decided to rush both vaccines, as the accelerating Ebola epidemic has taken more than 2,000 lives—most in recent weeks.
“This is absolutely unprecedented,” Marie-Paule Kieny, WHO assistant director-general, told reporters. “We must move as fast as possible.”
The chimpanzee cold vaccine
The first vaccine out of the gates, as noted, is a chimpanzee-derived replication defective adenovirus (ChAd3) vaccine being shepherded to clinical trial, as of last week, by GlaxoSmith Kline and the National Institute of Allergies and Infectious Diseases (NIAID). It is a disabled “chimp cold” virus genetically engineered to contain both Ebola and Marburg viral DNA.
That disabled virus slips into healthy cells as normal cold viruses do, and co-opts their machinery, causing them to pump out minute levels of Ebola protein. As levels are low, the healthy body has time to create an immune response—and arm it for future exposures.
In the Sunday Nature Medicine paper, a team led by NIAID’s Nancy Sullivan reported the vaccine protected four of four monkeys from Ebola for five weeks. A boost of a second vaccine (made with modified ankara virus (MVA)) brought full protection for ten months (as half of all monkeys died at ten months after just one ChAd3 shot).
The Sullivan team vaccine went to clinical trial in healthy people last Tuesday—sans boost. The vaccine may hit Africa soon after. (There is no timetable for the boost.)
“We have demonstrated, for the first time, to our knowledge, that both acute and durable immunity against EBOV [Ebola] can be achieved using a single inoculation (partial protection) or a prime-boost regimen (uniform protection),” Sullivan’s team said in the paper.
Livestock (‘VSV’) vaccine may be stronger
The second anti-Ebola vaccine that NIAID helps enter trial this month may offer longer protection--in one shot, proponents say.
Made of a recombinant Vesicular Stomatitis livestock Virus (rVSV), that vaccine is being tested by New Link Genetics Corp., which licensed it from the Public Health Agency of Canada. Its trial will be held at the Clinical Trials Center of Walter Reed Army Institute of Research.
University of Manitoba microbiologist Gary Kobinger recently found that rVSV vaccine protected 12 of 15 rodents against Ebola— the virulent (“7A”) kind--for one year, and offered complete protection at nine months. That vaccine was developed ten years ago by Heinz Feldmann, then with the Public Health Agency of Canada, and Geisbert. It is very similar to the next-gen rVSV vaccine Geisbert is testing at Profectus.
As noted, a Geisbert paper this year found all monkeys receiving a similar next-gen rVSV vaccine were fully protected for 14 months when challenged with the similar Marburg.
And in unpublished work presented at conferences, the next-gen anti-Ebola rVSV vaccine fully protected three of three monkeys against a wild-type strain of Ebola Zaire (again, the “7A virus”), Profectus CSO John Eldridge told DDD by email. "Three macaques received a single IM injection of the Profectus rVSVN4CT1 vectored Ebola-Zaire vaccine, and two were naïve controls. All were challenged with 1,000 PFU highly virulent low passage 7A Ebola virus 28 days after the single vaccination. All three vaccine recipients were completely protected against any disease, while the naïve controls died of fulminant Ebola hemorrhagic fever."
Meanwhile, the ChAd3 vaccine was only tried on the weaker, lab-derived 8A version in the Nature Medicine work. “With a challenge virus (8A) that is less virulent due to passaging in vitro, it is like challenging with a lower dose (less than one half),” said Kobinger. “These are conditions that would not necessarily translate into complete protection with the more virulent 7A isolate…From the human data I have seen from patients treated with ZMapp, the non-human primate model with the 7A virus is pretty close to what is seen in humans with the currently circulating Zaire in West Africa.”
Kobinger, now working on the New Link VSV vaccine, once did research on adenoviruses like ChAd3. “I was part of the team that isolated the first simian adenoviruses at U Penn in the early 2000s, and I worked since on different adenoviruses,” he said. “I decided this year that it was enough. Why try to always be as good as VSV when you can just use VSV?”
The bottom line: “I would prefer being vaccinated with a vaccine that protects against the 7A and set the bar high. ‘Long term’ in the [Nature Medicine] paper is not really long-term for a vaccine. What would happen after two years is anybody's guess. The higher the bar, the more likely it will really be long term--years not months.”
Debate over the published ChAd3 vaccine
ChAd3 proponents say there is not enough published work on 7A and 8A differences to draw conclusions. But Geisbert, too, wishes the ChAd3 vaccine was tried on the more virulent 7A, as the rVSV vaccines were in his above-mentioned unpublished Ebola work in monkeys, and in Kobinger’s mouse study. “This is a huge issue,” he contends. “We know USAMRIID has used a laboratory-adapted variant of Ebola-Zaire that has a predominance of 8U residues at the GP editing site (see this PLOS One paper for explanation of how viruses from patients change in culture). I have done [unpublished] studies where animals vaccinated with vaccines including the Ad5-based vaccine, previously shown to provide complete protection of monkeys against laboratory adapted ‘8U’ viruses, were unable to provide complete protection against wild type viruses with high populations of the wild type ‘7U’ residues.”
Furthermore, Geisbert said, a study has found VSV vaccines can even fight Ebola after infection. “The VSV-based vaccines can protect monkeys when given shortly after exposure (50 to 100 percent, depending on the filovirus).”
Geisbert believes “single injection protection is very important in responding to an outbreak. The prime boost [ChAd3] data is interesting, and they make a point about still having protection at 10 months. But in an outbreak you would not have time to prime and boost.”
He also finds Ebola vaccines made with MVA, like the ChAd3 vaccine boost, can have side effects. ChAd3 proponents disagree.
Finally, looking into concerns about neurological side effects, Geisbert found in 2012 no neurological problems in 14 of 14 monkeys given a VSV Ebola vaccine.
Already building up doses
Regardless, the ball is rolling. Canada has offered to donate 800 to 1,000 doses of the New Link rVSV vaccine, and Kobinger says from 1,500 to 15,000 doses of it are made bi-monthly.
The WHO says some 15,000 doses of the ChAd3 vaccine should be ready by year’s end.
Other Ebola vaccines
The Profectus rVSV vaccine should enter clinical trial in ten months. An adenovirus vaccine is being developed by Johnson & Johnson.
http://www.dddmag.com/articles/2014/09/two-anti-ebola-vaccines-historic-race
COMMENT: SINCE THIS ARTICLE, MERCK'S VACCINE HAS SHOWN TO HAVE PAINFUL SIDE EFFECTS, WHICH RESULT IN TRIALS BEING TEMPORARILY SUSPENDED.
And news a couple months later...
GlaxoSmithKline Ebola Vaccine Found Safe in Early Tests GlaxoSmithKline Plc (GSK)’s Ebola vaccine produced responses from the immune system and didn’t raise safety concerns in a study with 20 healthy adults, completing an initial step toward making it widely available.
The participants in the early-stage clinical trial in Maryland all produced antibodies, according to a preliminary report published yesterday in the New England Journal of Medicine. Two participants developed brief fevers within a day of vaccinations, but there were no serious adverse effects.
“It’s good news,” said Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, which is developing the vaccine with Glaxo. “If it was very toxic or didn’t induce good immune response, we couldn’t go on to the next step, but the proof of the pudding is efficacy.”
he tests showed that trial participants’ immune systems responded similarly to animals that gained protection from the virus after getting the vaccine, Fauci said. “It did what I hoped it would do.”
Glaxo and drugmakers including NewLink Genetics Corp. and Johnson & Johnson are racing to create a vaccine as the Ebola outbreak in West Africa continues to spread, with more than 15,000 infections and more than 5,600 deaths so far, according to the World Health Organization.
bloomberg.com
|
